Home NDC 63304-650-60 Dextromethorphan Hydrobromide and Quinidine Sulphate
Product NDC 63304-650
Requested package NDC 63304-650-60
11-digit product format 633040650
Labeler code 63304
Product ID 63304-650_5617af8d-e7b7-1c2c-e063-6294a90a7486
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextromethorphan Hydrobromide and Quinidine Sulphate
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA204196
Marketing category ANDA
Marketing start 2026-07-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Active strength 20 mg/1; 10 mg/1
Pharmacologic classes Antiarrhythmic [EPC]; Cytochrome P450 2D6 Inhibitor [EPC]; Cytochrome P450 2D6 Inhibitors [MoA]; Sigma-1 Agonist [EPC]; Sigma-1 Receptor Agonists [MoA]; Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Uncompetitive NMDA Receptor Antagonists [MoA]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204196-001 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20MG;10MG CAPSULE / ORAL AB 2026-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204196-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204196-001 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE 20MG;10MG CAPSULE / ORAL AB 2026-06-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204196-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Dextromethorphan Hydrobromide and Quinidine Sulphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 QUINIDINE SULFATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup J13S2394HE Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 63304-650-60 63304065060 60 CAPSULE in 1 BOTTLE (63304-650-60) 60 capsule 2026-07-30 0 Current